Active substance
Gemifloxacin
- SFDA 4
- US FDA 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FACTIVE 320MG F.C. TABLETS | 320 mg | Film-coated tablet · Oral use | 7 Blister | SAR 78.50 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| FACTIVE 320MG F.C. TABLETS | 320 mg | Film-coated tablet · Oral use | 5 Blister | SAR 58.90 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| FLOXAG 320MG F.C. TABLET | 320 mg | Film-coated tablet · Oral use | 5 Blister | SAR 55.90 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| FLOXAG 320MG F.C. TABLET | 320 mg | Film-coated tablet · Oral use | 7 Blister | SAR 74.50 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
Indications — CHI Daman Drug Formulary
COMMUNITY ACQUIRED PNEUMONEA; TRAVEL RELATED INFECTIONS-TREATMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FACTIVE | EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LG CHEM LTD | Discontinued | 4 Apr 2003 |
| GEMIFLOXACIN MESYLATE | EQ 320MG BASE | tablet · oral | ORBION PHARMS | Discontinued | 15 Jun 2015 |
Safety signals and safety-related labeling changes
- US FDA 3 May 2019 FACTIVE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.